title: The economic evaluation of personalised oncology medicines: ethical challenges.
abstract: Insights into the molecular drivers of cancer are providing opportunities for the development of new targeted treatments and more personalised approaches to cancer management. Drugs targeting mutant epidermal growth factor receptors, such as erlotinib and gefitinib, may provide more effective, safer and better tolerated treatment options compared with chemotherapy among appropriately selected patients with advanced non-small cell lung cancer (NSCLC). First-line access to these newer treatments remains unfunded after several considerations by the Pharmaceutical Benefits Advisory Committee and their assessment that these are not cost-effective treatments. We suggest that there may be evidentiary and ethical challenges associated with the assessment of the cost-effectiveness of personalised oncology medicines in Australia, and that a new approach is needed to determine the value and cost-effectiveness of personalised medicine.
authors.affiliation: Centre for Values, Ethics and Law in Medicine, University of Sydney, Sydney, NSW, Australia. jlewis@med.usyd.edu.au.
authors.forename: Jan R R
authors.initials: JR
authors.lastname: Lewis
authors.forename: Wendy L
authors.initials: WL
authors.lastname: Lipworth
authors.forename: Ian H
authors.initials: IH
authors.lastname: Kerridge
authors.forename: Richard O
authors.initials: RO
authors.lastname: Day
mesh_terms: D000970:Antineoplastic Agents / Q000191:economics* / Q000627:therapeutic use; D001315:Australia; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy / Q000191:economics; D003362:Cost-Benefit Analysis; D066246:ErbB Receptors / Q000037:antagonists & inhibitors; D000069347:Erlotinib Hydrochloride; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy / Q000191:economics; D009369:Neoplasms / Q000188:drug therapy* / Q000191:economics; D057285:Precision Medicine / Q000191:economics* / Q000941:ethics; D011799:Quinazolines / Q000191:economics / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D000069347:Erlotinib Hydrochloride; D066246:ErbB Receptors; D000077156:Gefitinib